AzTrials
AzTrials

Community-Based Participatory ResearchMBALNCT06482242

My Best Alaskan Life: A Community-Designed Intervention to Improve Youth/Young Adults' Sexual and Mental Health

A study testing My Best Alaska Life in people with Community-Based Participatory Research and Adolescent Behavior, run by University of Alaska Anchorage.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating "My Best Alaskan Life" (MBAL), an innovative online tool aimed at improving sexual and mental health literacy and behaviors. Read more about this study

Who is it for?
Ages 14 to 26 yearsHealthy volunteers can take part
What is being tested?
My Best Alaska Life
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
No sites listed yet
Study dates
1 May 2025to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 26 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Recruitment for the study will occur at 8 clinic/community sites (Figure 5), each enrolling 40 participants, inclu-sion criteria: (a) live in Alaska, (b) speak English, and (c) be between 14-26 years old, (d) have access to a smart phone or computer to self-administer surveys and access MBAL tool. Exclusion criteria include insufficient cognitive abilities to consent and previous use of the tool. During the initial phase (Weeks 0-4), participants are recruited across all 8 sites, and pre-intervention surveys are administered to all recruited participants. Recruit-ment will continue as needed at each site throughout the study, ensuring that new recruits complete the pre-intervention survey before receiving access to MBAL.

About this study

This project addresses critical public health disparities among Alaskan youth and young adults by developing and evaluating "My Best Alaskan Life" (MBAL), an innovative online tool aimed at improving sexual and mental health literacy and behaviors. By integrating motivational interviewing and the Health Belief Model, MBAL empowers individuals to make informed health decisions, thereby potentially reducing rates of sexually transmitted infections, HIV, and associated mental health issues. Long-term, this project aims to enhance overall health outcomes, particularly in underserved multicultural and Indigenous communities, while building local research capacity through undergraduate and graduate student engagement and mentorship.

Read the detailed description

SPECIFIC AIMS. Alaskan (AK) youth/young adults (Y/YA) face significant sexual and reproductive health disparities, leading the nation in sexually transmitted infections (STI), which increases risk of contracting HIV. (1-5) AK has the third and fourth highest rates of chlamydia and gonorrhea in the US, a 14% increase in syphilis cases compared to national rates between 2010-2020, and an estimated HIV prevalence of 142.3 per 100,000 (versus 80.7 nationally). (1, 2, 6-11) Concurrently, AK Y/YA experience disproportionately high levels of hopelessness and depression, increasing the likelihood of high-risk sexual behaviors. (12-15) Some 35.8% of AK Y/YA did not use a condom during their last sexual intercourse, and 16.9% do not use any pregnancy prevention method. (12-14) The Centers for Disease Control and American College of Obstetricians and Gynecologists recommend use of Reproductive Life Plan (RLP) tools, goal-setting guides for family planning. (16, 17) However, in previous pilot studies Y/YAs expressed need for an interactive tool to go beyond pregnancy intentions and address sexual and mental health disparities and diverse gender and sexuality identities.(18) Gaps: No RLP tools target sexual \& gender minority (SGM) Y/YA and the factors impacting their reproductive goals, including mental health, substance use, or relationship health. Recent systematic reviews of RLP tools note positive reception but lack evidence of efficacy in initiating knowledge or behavioral outcomes. (19) Proposed Project: To address these challenges, the team will employ "My Best Alaskan Life" (MBAL), an online decision-making tool crafted through a 4-year youth-centered, community-based participatory research effort (CBPR). Based on the Health Belief Model, MBAL integrates motivational interviewing to empower Y/YA to define priorities, identify supportive individuals, and enhance health literacy for discussions with healthcare providers and trusted adults. (20-28) This builds on two foundation and two implementation pilot studies where MBAL was refined by three youth advisory committees, five focus groups, and survey responses from 760 Y/YA (14-26) across AK.(18) Pilot outcomes endorsed MBAL's acceptability, appropriateness, feasibility, and capacity to enhance healthy sexual and mental beliefs, particularly for SGM participants. The proposed project builds on the CBPR approach, an established 4-year relationship with Y/YA and supportive adult partners across state and local health agencies, clinic and education health agencies across Alaska. This randomized controlled trial (RCT) will use a step-wedge design to assess MBAL's impact on Alaskan Y/YA through 8 clinical sites in rural and urban communities (n=40 participants per site, total n=320). This project will directly increase research capacity through annual cohorts of Y/YA co-investigators (5 undergraduate and 1 PhD student), recruited from the University of Alaska, who will be trained in qualitative research methods and mentored to lead the qualitative tool development, analysis, and dissemination.

Central hypothesis: MBAL has strong potential to effectively improve sexual \& mental health literacy and behavioral outcomes among Alaskan Y/YA through a self-guided, personalized assessment of health motivations, perceived threats, behavior evaluations, \& cultural factors that impact one's sexual choices, inclusive of SGM. (Measures with * are utilizing validated scales listed in Table 5 in C4.) AIM 1. Evaluate Short- and Long-Term Impact of MBAL Methods: Pre/Post Survey collected at enrollment/30 days/6 months (1A-1D). Analysis: Quantify changes in sexual health behaviors (measures: sexual health literacy*; condom/contraception use; HIV/STI testing; intention to delay sexual initiation.) Quantify changes in emotional/behavioral health (measures: mental health and well-being*; self-efficacy*; hopelessness*.) Quantify changes in commitment to factors impacting sexual health (measures: locus of control/perceived behavioral control*; motivation for change*; substance use*.) Conduct analyses to identify potential variations in effectiveness of MBAL for diverse groups. (measures: all.) AIM 2. Perform Process Evaluation Methods: Y/YA co-investigator coordinated interviews; semiannual, anonymous surveys with all stakeholders; feedback gathered at meetings; annual anonymous survey with Y/YA co-investigators. Analysis: Understand participant experience and perception of MBAL tool (measures: cultural competence; qualitative data (Y/YA co-investigator interviews). Understand experiences of research and community partners. (measures: Investment in Process and Product*; qualitative feedback. Understand experiences of Y/YA co-investigators. Measures: Student outcomes in research*.

AIM 3. Refine MBAL on Project Findings Methods: Feedback gathered at meetings; collaboration of research partners. 3A. Engage stakeholders in a collaborative process to make changes to MBAL based on RCT outcomes, to ensure it addresses multifaceted aspects of sexual and mental health. 3B. Y/YA co-investigators will integrate insights from MBAL and evaluation to finalize MBAL for dissemination as 1) a free state-wide tool, 2) for use by tribal and private health clinics, and 3) by school integrated health providers.

IMPACT: The MBAL tool, youth-developed dissemination and promotion campaign, and the evidence provided for RLP adaptations may serve as a framework for similar regions (ex. low provider access, multicultural and Indigenous youth, high sexual/mental health needs) to improve health outcomes. This proposal will also strengthen research opportunities by and for Alaskan Y/YA.

Being tested
My Best Alaska Life
Medical subject headings
Adolescent Behavior, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My Best Alaska LifeBehavioural

    MBAL's combination of digital innovation, inclusive content, and youth-driven design positions it as a leading-edge intervention in the field of sexual health, with the potential to significantly impact the lives of Y/YA in AK and beyond. The open-access digital website enhances the reach and engagement of MBAL, particularly among adolescents who may prefer to seek information and support online in a private, self-paced setting. By allowing youth to fill out this tool at their own pace and return to their home page as they want to reflect/change answers, they can update it as their lives change. Additionally, MBAL incorporates interactive elements (question types of open response, ranking, scales, drag/drop; journaling prompts \& space) and personalized features (ex. avatars of common AK animals designed by Y/YA), allowing users to tailor their life planning experience according to their individual needs and preferences and return to their answers.

Study groups in NCT06482242
Study groupRoleWhat they receive
Delayed accessOtherThe step wedge design ensures that everyone has access to the intervention but data will be collected prior to the intervention being implemented at each site.
Receives: Behavioral: My Best Alaska Life
Immediate accessOtherSites will be randomized to receive intervention and those who receive intervention initially, will then be compared to those who do not at the same time period.
Receives: Behavioral: My Best Alaska Life

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motivation for Change

    This validated shortened tool includes 3 questions per topic area, with four topics areas: sexual and reproductive health, emotional and behavioral health, life planning, \& sub-stance use.

    Measured: Baseline, immediate post, and 6 months post

  2. Sexual Health

    Condom/contraception use; HIV/STI testing; \& intention to delay sexual initiation (if not sexually active).

    Measured: Baseline, immediate post, and 6 months post

  3. Mental Health & Well-being

    The Ryff Psychological Wellbeing Scale is an 18-item scale measuring six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.

    Measured: Baseline, immediate post, and 6 months post

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start1 May 2025 (estimated)
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
The research team will utilize a stepped wedge randomized clinical trial with 8 clinic/community sites, each recruiting 40 participants, for a total of 320 participants. Each site will transition from control (pre-intervention) to intervention (post-intervention) in a randomized, stepwise fashion. Sites are randomly assigned to different start times (in 4-week intervals) for the intervention, ensuring that every site eventually receives the intervention, while maintaining methodological rigor. From Weeks 0-4, baseline recruitment and pre-intervention survey administration will occur at all 8 sites. In Weeks 5-8 (Time Period 1), participants at Site 1 will start the intervention (each consented participant will be emailed a link to MBAL and the post-intervention survey upon completion.) In Weeks 9-12 (Time Period 2), participants at Site 2 will start the intervention, while Site 1 continues to recruit until 40 participants are enrolled in the study, and this pattern will continue.
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06482242
Sponsor's protocol ID
UAlaskaAnchorage
Acronym
MBAL
Status last verified
Jun 2024
First submitted
25 Jun 2024
Last updated
1 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing My Best Alaska Life in people with Community-Based Participatory Research and Adolescent Behavior, run by University of Alaska Anchorage.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motivation for Change (time frame: Baseline, immediate post, and 6 months post). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in